Philips Medical Systems Nederlands recalls OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

Recall date

May 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2300-2018

FDA classification

Class II

Brand / firm

Philips Medical Systems Nederlands

Sold / distributed

US nationwide distribution.

Why it was recalled

The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028